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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 4-0 S/A PS-5 PRM MP; SUTURES - ABSORBABLE
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ETHICON INC. PDSII UD 18IN 4-0 S/A PS-5 PRM MP; SUTURES - ABSORBABLE Back to Search Results
Catalog Number Z594G
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/20/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported that a patient underwent an endoscopic ob-gyn procedure on (b)(6) 2020; and a suture was used.During the procedure, when a scrub nurse was opening the package on the mayo table for using dermal suturing of trocar hole, it was found that the needle had been detached from the suture from the beginning.It was not a control release needle.It was observed that the needle had been detached from the suture from the beginning.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
PDSII UD 18IN 4-0 S/A PS-5 PRM MP
Common Device Name
SUTURES - ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9995214
Report Number2210968-2020-03456
Device Sequence Number4442457
Product Code NEW
UDI-Device Identifier10705031061477
UDI-Public10705031061477
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
N18331
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberZ594G
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/20/2020
Initial Report FDA Received Date04/24/2020
Patient Sequence Number1
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